|
| |
Mandatory Inspection
of Non-Amenable (Exotic) Species
National Advisory Committee on Meat and Poultry Inspection
May 2000 Public Meeting
Issue Paper on Current Thinking
Purpose
At its May 2000 meeting, the National Advisory Committee on Meat and
Poultry Inspection (NACMPI) will be briefed on additional information
gathered and additional issues identified in the exploration of
expanding the list of species under mandatory USDA inspection. The
Committee will have the opportunity to make additional recommendations
and identify additional data needs to be reflected in the discussion
draft of the Concept Paper on Extending USDA's Inspection Program to
Additional Species, which is to be completed by November 2000.
At its November 1999 meeting, the Committee was briefed on key
aspects of the issue, reviewed the preliminary draft concept paper
prepared by FSIS to support discussion and policy development, and
discussed key aspects of the issue. The Committee also made
recommendations. The NACMPI endorsed the application of criteria for
resolving the issue of which animals (and their products) that are
intended for human consumption should be subject to mandatory
inspection, as outlined in the draft concept paper. The Committee also
requested more detail in the paper to address the available public
health data and microbiological testing, to reflect economic concerns,
and to outline issues pertinent to interstate and international shipment
of exotic species and their products. The Committee also asked that the
Agency address and resolve the specific issue of nitrites in
non-amenable (exotic) species.
Discussion
FSIS has given careful consideration to the NACMPI’s recommendations
and is in agreement that additional species (such as ratites, quail, and
squab) should be added to those currently under mandatory inspection in
order to be consistent with the USDA vision of a public health,
risk-based, seamless Federal/State inspection system. The draft concept
paper (Attachment 1) presents a conceptual framework that can serve as
the basis for further dialogue and for determining which species of
animals should be added to the list of those that are already amenable
to USDA inspection. The paper presents the statutory and regulatory
basis for mandatory and voluntary inspection, a public health rationale
for considering additional species, a preliminary economic assessment of
the costs and benefits of adding to the list of species under mandatory
inspection, and a set of criteria to consider in making the decision as
to which species should be added to the list. The Agency currently does
not have the regulatory and/or statutory authority to inspect
non-amenable/exotic species; the species are "non-amenable" to
inspection. Identified primary recommended criteria for determining the
list of exotic animals and birds that should be subject subject to
inspection include:
- Consumption
. The species and its products are used as human
food.
- Potential public health hazards.
There must be sufficient
microbiological risk for FSIS to mandate inspection and there must be
evidence that inspection can mitigate the risk. Species that are shown
to be associated with documented human illness (e.g. zoonotic diseases)
should be given priority. There is no question that non-amenable/exotic
species can be a vector for agents of public health concern. A
preliminary review of the scientific literature shows that exotic
species appear to present health risks similar to those associated with
meat and poultry products subject to mandatory inspection. Additional
data has been gathered since the May 1999 meeting. (See Attachment 2,
Table of Diseases Known to Exotic Species; and Attachment 3,
Bibliography of Diseases Known to Exotic Species.) These data are
sufficient to answer many, but not all public health questions
associated with non-amenable/exotic species.
- Exposure.
Market size – volume of product produced and volume
of product consumed – affects the extent to which the population is
exposed to potential public health hazards. Products from the species
should be produced and consumed in a large enough volume to make
exposure a public health concern (especially to at-risk populations).
Additional data needs have been identified since November 1999.
Acquiring these data would aid in the estimation of exposure, risk and
potential costs and benefits of extending mandatory inspection to
certain exotic species. The additional data requirements identified
are:
- Exotic species production numbers and numbers of establishments
for the years
1995-99.
- Forecasted production numbers and numbers of establishments
slaughtering/processing exotic species for the year 2000 and beyond.
- Average cost to retrofit slaughter equipment and facilities for
selected exotic species.
- Amount of reimbursement to state inspection programs.
- Amount collected from user fees in the voluntary inspection
program, years 1995-99.
- Average number of hours to inspect exotic species, by species
type.
- Average cost to conduct FSIS chemical residue testing per
species.
- Total inspection costs (number of inspectors, salaries, travel
expenditures) for an estimated 159 establishments.
Additional practical criteria that need to be considered include:
- Inspection environment.
An establishment with a grant of
inspection must be available and within a reasonable geographic
location. Are effective inspection procedures for the exotic species
compatible with current inspection procedures and practices for animals
and birds subject to mandatory inspection?
- Limited inspection resources.
The allocation of limited
inspection resources should be based on the relative food safety risks
presented by different animal flesh foods, and the potential benefits
of inspection. Market size – the level of production and the level of
consumption – affects the amount and efficiency of inspection
resources.
Costs. The potential costs to FSIS, to industry and to consumers
must be identified and estimated. In addition to information presented
in the draft concept paper, additional potential costs have now been
identified. These are summarized below:
- Industry potential start-up costs would include retrofit of
slaughter equipment and facilities, and costs to meet HACCP
requirements, including development of a HACCP plan and HACCP training
for plant employees. Because non-amenable/exotic species are not
currently considered either meat or poultry, unless they are under
voluntary inspection, plants producing them are not yet subject to the
entire range of Pathogen Reduction and HACCP requirements.
Annual operating costs would include HACCP recordkeeping and the cost
of analyzing samples for relevant microorganisms.
- FSIS potential start-up costs would include the development of
baseline microbiological studies and the subsequent development of
performance standards for pathogen reduction; chemical residue testing;
the establishment of appropriate testing criteria and procedures and
the costs to evaluate the equivalence of foreign food regulatory
systems in the area of exotic species. Annual operating costs would
include inspection service for approximately 159 federally inspected
plants and 342 state-inspected plants, the costs of verifying
compliance with the PR/HACCP rule; the loss of user fees resulting from
the termination of the voluntary inspection program; and reimbursement
to state programs for up to 50 percent of the cost of state inspection
of exotic species.
- Costs to consumers are uncertain. For example, if the burden of
paying for inspection is removed from industry, companies might be able
to charge less for their products. If mandatory inspection improves the
marketability of these products but the supply does not expand to meet
the increased demand, prices could rise. The exact measure of these
shifted costs is not yet known.
Process and relevant legal authorities. Expansion of the list of
poultry species amenable to mandatory inspection may be possible
without legislative change; that is, through the public rulemaking
process.
Expansion of the list of meat species subject to mandatory
inspection would, however, require both a statutory change and
rulemaking. The Federal Meat Inspection Act (FMIA) would need to be
amended. Amendment of the inspection laws would be appropriate to
affirmatively permit interstate and international shipment of exotic
species. In April 2000, hearings were held on proposed
legislation to eliminate the prohibition on interstate/international
shipment of state-inspected meat/poultry. (The Administration
transmitted proposed legislation to Congress.) These amenable species
issues may be subject to legislative review, as part of that process.
- The Federal Food, Drug and Cosmetic Act (FFDCA) does not
specifically address the issue of inspection oversight for any
particular species of animal, but does cover "food" in general.
- USDA authority for voluntary inspection of exotic species is
derived from the Agricultural Marketing Act and not the Federal Meat
Inspection Act or Poultry Products Inspection Act. FSIS regulations
identify reindeer, elk, deer, antelope, water buffalo and bison as
exotic animals eligible for voluntary inspection. Quail and pheasants
are exotic poultry species similar to chickens, ducks, and turkeys,
poultry species for which inspection is required. Because exotic
species are not considered meat or poultry under the federal inspection
laws, industry must reimburse the government for the cost of
inspection. (See Attachment 1, draft concept paper.)
- State inspection of non-amenable species
. Several states now
conduct inspection of non-amenable species. (See Attachment 4, State
Inspection of Non-Amenable Species.) Currently, FSIS accepts
state-inspected exotic meat products for inclusion in amenable product
formulations in federally inspected plants. If exotic animals were
subject to mandatory inspection, state-inspected products from exotic
species would no longer be permitted to move in interstate commerce.
(This obstacle would be removed if legislation currently being
considered by Congress were to become law.) Because state inspection of
exotic species is not covered by the "at least equal to" requirements
of the inspection laws, FSIS does not directly review state inspection
programs for exotic species for purposes of audit or state program
comprehensive review. However, FSIS coordinates with state inspection
programs on exotic inspection issues.
Nitrite use. In addition, consideration of extending mandatory
inspection needs to address related issues, such as the use of
nitrite/ate. The Committee asked whether nitrite will be permitted to be
used in products from non-amenable species if certain exotic species
become subject to mandatory inspection.
- The use of nitrite/ate in meat and poultry products is permitted on
the basis of the "prior sanction" provision of the Federal Food, Drug
and Cosmetic Act. Prior sanctions "grandfather" the uses of additives
based on their documented use prior to 1958. With regard to meat
products prior sanctions apply only to the species that USDA regulated
prior to 1958.
- In 1958, new criteria for determining the safety of additives were
established. For several years, the National Toxicology Program (NTP)
has been reviewing aspects of nitrite use and is expected to issue a
statement or report in the fall of 2000 that will address public health
issues, if any exist. The NTP comments will influence FDA's
determination on the future status of nitrites which would impact their
use in additional species not currently under inspection. However, more
information is being gathered regarding the regulatory and legislative
procedures that pose potential barriers to expanding the use of
nitrite/ate in non-amenable species.
Questions
- Does the Committee believe that the Concept Paper and the data
needs described above sufficiently describe the data that are necessary
to refine estimates of risks and benefits and to support legislative
and/or rulemaking processes? If not, what additional data points are
needed? Do members of the Committee have data that address the data
needs?
- Does the Committee wish to raise substantive new issues relevant to
the extension of mandatory inspection to certain exotic species?
- Does the Committee wish to identify a procedure that the Agency
should pursue in resolving the potential regulatory or legislative
barriers regarding the use of nitrite/ate in non-amenable species?
Contact Person
Dr. Robert C. Post, Director, Labeling and Additives Policy Division
(205-0279; fax 205-3625).
Attachments
Attachment 1: Draft concept
paper, 10/99
Attachment 2: Table of Diseases Known
to Exotic Species
Attachment 3: Bibliography of Diseases Known to Exotic Species
Attachment 4: State Inspection of Non-Amenable Species (LaFontaine,
December 1999)
|
